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Regulatory Affairs Officer

2 months ago

London, United Kingdom SUN PHARMA Full time

The Regulatory Affairs (RA) Officer is primarily responsible for ensuring the appropriate licensing, marketing and legal compliance of Sun Pharma’s pharmaceutical and medical products in order to control the safety and efficacy of these products. The RA Officer combines scientific, legal and business knowledge to ensure Sun Pharma’s products meet the required legislation. Package Leaflet User test reports.
Is responsible for the preparation of SmPC, labelling and PILs texts according to the Quality Review of Documents (QRD) format.
Is responsible for proof reading of art work of packaging materials.
Ensure dossier technical content is optimal and aligned with UK Regulatory data requirements for new UK Marketing Authorisation Applications
Liaises with regulatory colleagues in the different country offices, corporate groups and competent authorities (MHRA) and third parties on regulatory issues.
Works closely together with internal customers such as Research & Development, Artwork, Pharmacovigilance, Quality Assurance, Logistics, Finance, Business Development, Sales.
Keeps the Regulatory Information correct and accessible for other stakeholders.
Bachelor or Master Degree (preferably in Life Sciences, Languages or Law)
Rounded knowledge of the UK and EU Regulatory Framework (directives, regulations, guidelines)
Good verbal and written communication skills in English
Good IT skills including familiarity with Microsoft Office packages and specific packages/portals such as eCTD software, XEVMPD software, TVT, CESP, EMA gateway, MHRA and CBG portal.
Good organization and project management skills